The Application of Root Analogy Implant in Immediate Implantation

NCT ID: NCT06449391

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-06-30

Brief Summary

The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery.

Detailed Description

The current clinical implant techniques used include immediate implantation, early implantation, and delayed implantation. With the acceleration of the current pace of life, immediate implantation is increasingly favored by patients due to its advantages such as fewer surgeries, shorter waiting times, and less impact on aesthetics. The research group has shown that the mismatch between traditional implants and extraction sockets in immediate implantation surgery has caused some complications. Therefore, it is believed that 3D printed personalized root shaped implants with certain roughness are more suitable for use in immediate implantation surgery. A 3D printed personalized root implant system jointly developed by Zhejiang University School of Medicine Affiliated Stomatology Hospital, Zhejiang University School of Mechanical Engineering, and Hangzhou Ya Natural Technology Co., Ltd. The implant part of this implant system is implanted into the bone using laser melting printing technology in additive manufacturing methods. The raw material is pure titanium powder, and research results in New Zealand white rabbits and beagles have confirmed that the implant has good bone bonding ability, which can shorten surgical time, reduce surgical frequency, compress implant cycle, restore chewing function, and other advantages. The relevant research results have been published in the top oral journal Journal of Dental Research, and the chemical composition and biological safety of the material have been tested by the Zhejiang Medical Device Inspection and Research Institute (test report number: Z20221903), Z20222527，G20233158）。 The base and other accessories are cut from titanium rods using conventional reduction manufacturing techniques.

Conditions

Dental Implantation; Dental Implants; Osseointegration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

implanted group

This study is a single arm study, with only immediate implantation of root analogy implants

Group Type: EXPERIMENTAL

RAI

Intervention Type: DEVICE

Immediate implantation

Interventions

RAI

Immediate implantation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age:20-60 years old, gender unlimited
• Good oral hygiene
• No systemic diseases
• There are irreparable residual roots, no obvious apical periodontitis, no looseness greater than degree II, and the tooth position includes four quadrant anterior teeth and premolars
• Root length greater than 10 mm, and no significant bone resorption at the alveolar crest
• There is no significant displacement of adjacent teeth and no significant elongation of opposing teeth
• The bone density of the target implant area is Class II and Class III
• The lateral bone wall of the lips (cheeks), palate (tongue) is intact and larger than 1mm
• The subjects are able to understand the purpose of the experiment, willing to -cooperate with surgical treatment and follow-up, voluntarily participate in the experiment, and sign an informed consent form.

Exclusion Criteria

• Patients with moderate to severe periodontitis
• Missing proximal and distal adjacent teeth in the target residual root
• Residual roots with root adhesion
• The target implant area has a bone density of Class I or IV
• Acute infectious disease or metabolic bone disease activity period
• Patients with diabetes history and poor blood glucose control (fasting blood glucose ≥ 8.8 mmol/L L)
• Patients with liver and kidney dysfunction (AST, ALT ≥ 1.5 times ULNULN, creatinine ≥ 1.5 times ULNULN)
• Individuals with a history of osteoporosis
• Individuals with a history of malignant tumors or other serious illnesses who are not suitable for surgery
• Individuals with mental disorders and lack of autonomous behavior ability Pregnant women, lactating or menstruating women, and women with pregnancy plans within six months
• Various possible causes of imaging artifacts in the surgical area
• Receiving medication that may affect bone metabolism (such as bisphosphonates) within the past 3 months
• The researchers estimate poor compliance or other factors that are not suitable for conducting this experiment.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Dental Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yixu Chen

Role: CONTACT

11818293@zju.edu.cn

+86 571 8721 9287

Facility Contacts

Xiaowen Yu, Doctor

Role: primary

yuxiaowen@zju.edu.cn

+8615068107876

Other Identifiers

2024035

Identifier Type: -

Identifier Source: org_study_id